Location: Ireland
URL: http://www.bond-personnel.com

Description:
My Galway based client has a 6-9 month for a Compliance Specialist:

Duties & Responsibilities: Lead & participate actively in the internal audits conducted per audit schedule.
Maintenance of audit schedule.
Preparation of audit reports listing audit findings to be reviewed and approved
Support relevant areas in preparation of response plans to audit findings
Inputting audit responses on the electronic Audit System.
Drive preparations for hosting of external audits
Drive on time closure of audit actions through use of electronic reporting systems and consistent communication
Participate in audit council conferences and communication of relevant issues
Generation and approval of change requests
Provide support to Quality Systems re system/process improvements.
Prepare weekly reports for inclusion in weekly senior site reports.
Verification of checklist for adherence to Part 11 for software applications.
Data integrity audits for submissions.

Qualifications/Experience: A third level degree in a relevant area such as Science, Engineering or equivalent is essential. (Further postgraduate study in Quality related disciplines would be of benefit).
Understanding, and preferably, training in the relevant Regulations e.g 21 CFRs Part 820, 210/211, ISO 13485:2003, MDD & AIMD essential.
Previous auditing experience, preferably as a Lead Auditor, essential.
Certification to recognized Lead Assessor qualification essential.
Excellent Verbal and written communication skills are essential for this role

Salary dependent on experience

To take advantage of this opportunity call Tanya on (090)6493882 or send your cv



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